Article 10 in our Maturity Model series
Executive Summary
The organization domain focuses on the structural elements that support effective clinical trial disclosure. It encompasses roles and responsibilities, cross-functional collaboration, and organizational alignment. A properly coordinated organization ensures efficient disclosure processes, clear accountability, and adaptability to evolving regulatory requirements.
Why this domain matters
A well-structured organizational approach to clinical trial disclosure ensures consistency, efficiency, and compliance across all transparency efforts. Clear roles, responsibilities, and reporting lines enable effective decisionmaking and accountability, reducing the risk of missed deadlines or incomplete disclosures. Strong cross-functional collaboration facilitates the smooth flow of information and expertise among departments, enhancing the quality and timeliness of disclosed data. An optimized organizational structure allows for better resource allocation and scalability, enabling sponsors to adapt to changing regulatory landscapes and growing disclosure requirements. Finally, a mature organizational approach fosters a culture of transparency, aligning disclosure activities with broader corporate values and building trust with patients, healthcare professionals, and regulatory bodies:
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This interactive tool will guide you through a comprehensive evaluation of your organization's disclosure practices, enabling you to identify strengths, pinpoint areas for improvement, and chart a clear path toward greater transparency and compliance.
About the author
Thomas Wicks
Head of Transparency Operations, Citeline
Thomas Wicks is an experienced strategic leader with over 20 years in life sciences. As Head of Transparency Operations at Citeline, he spearheads strategy for TrialScope's industry-leading disclosure solutions. Thomas is an established thought leader, having spoken at over 60 conferences and authored over 40 publications on disclosure requirements and transparency trends. Thomas is motivated by empowering teams to accelerate solutions that honor trial transparency.